K Number
K962194
Device Name
MLI SOFT TISSUE SCREW & WASHER SYSTEM
Date Cleared
1996-07-30

(53 days)

Product Code
Regulation Number
888.3040
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MedicineLodge, Inc. soft tissue anchoring bone screws and washers are indicated for use in soft tissue graft fixations to the femur or tibia, or both, during cruciate ligament, tendon or other soft tissue graft (e.g. semitendinosus) repair procedures.
Device Description
The MLI Soft Tissue Screw and Washer System is an assembly unit consisting of MLI Soft Tissue Anchoring Screws and MLI Washers. The screws are provided in standard sizes (4.5 mm Cortical and 6.5 mm Cancellous) and conform to ISO 5835. They are self-tapping and inserted manually with a 3.5 mm hex driver. The washers are universally compatible with both screw sizes and come in three design configurations (Round, Triangular, Oval) with spikes on the distal side to penetrate bone and anchor the graft.
More Information

Not Found

Not Found

No
The device description and performance studies focus on mechanical properties and physical components, with no mention of AI or ML.

Yes
The device is indicated for use in soft tissue graft fixations during cruciate ligament, tendon, or other soft tissue graft repair procedures, which are therapeutic interventions.

No

This device is described as an assembly unit of screws and washers used for soft tissue graft fixations. Its intended use and description pertain to surgical repair procedures, not to the diagnosis of a condition or disease.

No

The device description clearly outlines physical components (screws and washers) and their material properties and testing, indicating it is a hardware medical device, not software-only.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for "soft tissue graft fixations to the femur or tibia... during cruciate ligament, tendon or other soft tissue graft repair procedures." This describes a surgical implant used in vivo (within the body) to physically anchor tissue.
  • Device Description: The device is described as "soft tissue anchoring bone screws and washers," which are physical components used in surgery.
  • IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform such testing.

The information provided clearly indicates a surgical implant, not a diagnostic device.

N/A

Intended Use / Indications for Use

MedicineLodge, Inc. soft tissue anchoring bone screws and washers are indicated for use in soft tissue graft fixations to the femur or tibia, or both, during cruciate ligament, tendon or other soft tissue graft (e.g. semitendinosus) repair procedures.

Product codes (comma separated list FDA assigned to the subject device)

MBI

Device Description

The MLI Soft Tissue Screw and Washer System consists of screws and washers designed to be used as an assembly unit for soft tissue graft fixations. The MLI Soft Tissue Anchoring Screws are provided in standard sizes: 4.5 mm (Cortical) diameter with lengths from 30 mm to 60 mm (in 2 mm increments), and 6.5 mm (Cancellous) diameter with lengths from 20 mm to 55 mm (in 5 mm increments). These screws are designed to conform to ISO 5835 standards, are self-tapping, and are manually inserted using a standard 3.5 mm hex driver. The MLI Washers are universally compatible with both 4.5 mm and 6.5 mm MLI Screws and come in three design configurations: Round (14 mm, 17 mm, 20 mm diameter), Triangular (17.5 mm, 20.5 mm diameter), and Oval (19 mm, 22 mm diameter). The washers feature spikes on their distal side to penetrate host bone and anchor the graft. The materials, method of manufacture, method of sterilization, and device packaging are equivalent to those used for selected predicate devices.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

femur or tibia

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

MedicineLodge, Inc. conducted device testing on screw/washer configurations of the MLI Soft Tissue Screw and Washer System to assess its performance. These tests were then used to compare the performance of the MLI Screws and Washers to a commercially marketed soft tissue screw and washer system.
The following tests were conducted using the indicated screw/washer combinations:

  • (i) Test #1: Fixation strength of the MLI 4.5mm X 52mm Cortical Screw and MLI-Small Round Washer (13 mm) in Static Bone Patellar Tendon Tensile Testing in a Bass Wood Model.
  • (ii) Test #2: Fixation strength of the MLI 4.5mm X 52mm Cortical Screw and MLI-Large Round Washer (18 mm) in Static Bone Patellar Tendon Tensile Testing in a Bass Wood Model.
  • (iii) Test #3: Fixation strength of the MLI 4.5mm X 52mm Cortical Screw and MLI-Trianqular Washer (11.5 mm) in Static Bone Patellar Tendon Tensile Testing in a Bass Wood Model.
  • (iv) Test #4: Fixation strength of the MLI 4.5mm X 52mm Cortical Screw and MLI-Football Washer (11.5 mm x 8.5 mm) in Static Bone Patellar Tendon Tensile Testing in a Bass Wood Model.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Device testing was conducted on a variety of screw/washer configurations of the MLI Soft Tissue Screw and Washer System. The mode of failure for all MLI Screw and Washer configurations was consistent: the ligament pulled out from under the washer. This mode of failure is consistent with results obtained by Matthews et.al and Kurosaka et.al. The yield load data was considered the best measure of the observed mode of failure, as yield of the graft construct results in permanent deformation of the ligament. When the yield load results for the various MLI Soft Tissue Screw and Washer System screw/washer constructs were compared to a currently marketed screw/washer construct (predicate device), the MLI screw/washer constructs performed as well as or better than the predicate screw/washer construct. It is noted that the marketed washer sizes for the MLI system will be larger than those tested, which is expected to increase fixation strength in clinical application.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Linvatec Concept Soft Tissue Anchoring Implants, Arthrotek Ligament Screw System, Mitek Screws and Washers

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.

0

JUL 30 1996

Premarket Notification

510(k) Summary of Safety and Effectiveness Information

DATE OF SUMMARY PREPARATION

June 5, 1996

MANUFACTURER

MedicineLodge, Incorporated 152 South 600 West Logan, Utah 84321 Telephone: (801) 753-7675 (801) 753-7698 Fax:

MANUFACTURER CONTACT PERSON

Wade Fallin Vice President of R&D MedicineLodge, Inc. 152 South 600 West Logan, Utah 84321 Telephone: (801) 753-7675 (801) 753-7698 Fax:

PROPRIETARY NAME

MedicineLodge, Inc. (MLI) Soft Tissue Screw and Washer System

COMMON NAMES

Orthopedic Bone Screw Orthopedic Washer

CLASSIFICATION NAME

Non-degradable Soft Tissue Fastener

CLASSIFICATION REFERENCE

Currently, no FDA classification exists for Non-degradable Soft Tissue Fasteners

DEVICE PRODUCT CODE

MBI

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CLASSIFICATION PANEL

Orthopedic and Rehabilitation Devices

PROPOSED REGULATORY CLASS

In accordance with FDA classification of fixation bone screws and orthopedic washers as Class II medical devices, this device system is proposed for placement in Class II.

REASON FOR PREMARKET NOTIFICATION

The MLI Soft Tissue Screw and Washer System is a new medical device proposed for placement in Class II.

SPECIAL CONTROLS

At this time, Food and Drug Administration generated Performance Standards applicable to MedicineLodge, Inc. Soft Tissue Screws and Washers are not in force. However, MedicineLodge, Inc. has conducted mechanical testing on four screw/washer configurations to demonstrate the substantial equivalence of the device. Additionally, MedicineLodge, Inc. utilizes materials and vendor certifications, in-house standard operating procedures (SOP's), and ASTM standards, as appropriate.

INDICATIONS FOR USE

MedicineLodge, Inc. soft tissue anchoring bone screws and washers are indicated for use in soft tissue graft fixations to the femur or tibia, or both, during cruciate ligament, tendon or other soft tissue graft (e.g. semitendinosus) repair procedures.

SUBSTANTIALLY EQUIVALENT PREDICATE DEVICES

MedicineLodge, Inc. believes that several commercially available devices are substantially equivalent to the MLI Soft Tissue Screw and Washer System. Within the proposed class, the following devices are used as predicate devices for comparison:

  • Linvatec Concept Soft Tissue Anchoring Implants 1) Linvatec, Inc.; Largo, FL
  • Arthrotek Ligament Screw System 2) Arthrotek, Inc., Ontario, CA
    1. Mitek Screws and Washers Mitek Surgical Products, Inc .; Norwood, MA

MedicineLodge, Inc. believes that the information presented below demonstrates the substantial equivalence of the MLI Soft Tissue Screw and Washer System when compared to the above selected predicate devices.

2

SUBSTANTIAL EQUIVALENCE COMPARISON

To begin, the materials, method of manufacture, method of sterilization, and device packaging for all MLI Soft Tissue Screw and Washer System components are equivalent to those used for the selected predicate devices.

MLI Soft Tissue Screws and Washers are indicated for use in soft tissue graft fixations to the femur or tibia, or both, during cruciate ligament, tendon or other soft tissue graft (e.g. semitendinosus) repair procedures. The previously listed predicate device systems are similarly indicated for procedures involving soft tissue reconstruction.

The MLI Soft Tissue Screws and Washers are designed to be used as an assembly unit. The MLI Soft Tissue Anchoring Screws are provided in standard sizes, as tabulated below:

Screw DiameterScrew Length
4.5 mm (Cortical)30 mm - 60 mm, in 2 mm increments
6.5 mm (Cancellous)20 mm - 55 mm, in 5 mm increments
  • Frances of the contract of the contribution of the many of the may be interest of the may be the may be the may be the may be the may |

MLI Screws are equivalent in design to currently marketed standard bone screws, with all threads and defining screw features conforming to ISO 5835, Metal Bone Screws with Hexagonal Drive Connection, Spherical Under-Surface of Head, Assymetrical Thread Dimensions. The screws are self-tapping and are designed to be manually inserted using a standard 3.5 mm hex driver. Engineering Drawings are provided in Exhibit I for reference.

The MLI Washers are designed to be universally compatible with both the 4.5 mm and 6.5 mm MLI Screws and are provided in the three following design configurations to allow the surgeon a variety of washers to choose from:

Washer ShapeWasher Diameter
Round14 mm, 17 mm, 20 mm
Triangular17.5 mm, 20.5 mm
Oval19 mm, 22 mm

The washers possess spikes spaced equidistant from each other on the distal side of the washer to penetrate the host bone and thus anchor the graft in place. Engineering drawings of the washers are also provided in Exhibit I for reference.

Although the washer design configurations listed above may vary slightly from standard washers used in soft tissue repair, testing performed by MedicineLodge, Inc. shows that these differences do not compromise the performance of the washers relative to standard round washers in their intended clinical use. This testing is discussed below.

DEVICE TESTING

MedicineLodge, Inc. has conducted device testing on a variety of screw/washer configurations to assess the performance of the MLI Soft Tissue Screw and Washer

3

System. These results were then used compare the performance of the MLI Screws and Washers to a commercially marketed soft tissue screw and washer system.

The following tests were conducted using the indicated screw/washer combinations:

  • (i) Test #1: Fixation strength of the MLI 4.5mm X 52mm Cortical Screw and MLI-Small Round Washer (13 mm) in Static Bone Patellar Tendon Tensile Testing in a Bass Wood Model.
  • (ii) Test #2: Fixation strength of the MLI 4.5mm X 52mm Cortical Screw and MLI-Large Round Washer (18 mm) in Static Bone Patellar Tendon Tensile Testing in a Bass Wood Model.
  • (iii) Test #3: Fixation strength of the MLI 4.5mm X 52mm Cortical Screw and MLI-Trianqular Washer (11.5 mm) in Static Bone Patellar Tendon Tensile Testing in a Bass Wood Model.
  • (iv) Test #4: Fixation strength of the MLI 4.5mm X 52mm Cortical Screw and MLI-Football Washer (11.5 mm x 8.5 mm) in Static Bone Patellar Tendon Tensile Testing in a Bass Wood Model.

The mode of failure for all MLI Screw and Washer configurations was similar for all screw/washer constructs tested, wherein the ligament pulled out from under the washer. The modes of failure are also consistent with results obtained by Matthews et.al and Kurosaka et.al where the site of failure was at the point of ligament anchorage to the implant. It is important to note that yield of the graft construct results in permanent deformation of the ligament, which can in turn result in a loose or lax graft. For this reason, MedicineLodge, Inc. believes that the yield load data best measures the observed mode of failure.

When the vield load results for the various MLI Soft Tissue Screw and Washer System screw/washer constructs were compared to the currently marketed screw/washer construct, the MLI screw/washer constructs all performed as well or better than the predicate screw/washer construct.

It is important to state that the washer sizes that will comprise the MLI Soft Tissue Screw and Washer System will be larger than those tested. The thus increases the distal surface area of the washers, which in turn should result in increased fixation strength of the graft construct in true clinical application of the product. In particular, for the Football washer (tested size: 11.5mm; marketed sizes: 19mm and 22mm), this size increase should provide additional assurance that the device will perform equivalent to the predicate screw/washer construct.

It is our belief that these results confirm the equivalence of the MLI Soft Tissue Screw and Washer System relative to the tested predicate device in testing devised to simulate clinical application of the product,

CONCLUSION

Based on the design concept, indications for use, use of standard materials, and feature comparisons to the selected predicate devices, MedicineLodge, Inc. believes that sufficient evidence exists to conclude that MLI Soft Tissue Screw and Washer System is

4

substantially equivalent to existing legally marketed soft tissue anchor screw and washer systems.

イ..

ﻧﺎ ﺗﺤﻘﻴﻘﺎ

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Table 1 on the following page summarizes the relevant feature comparisons between the MLI Soft Tissue Screw and Washer System and the selected predicate devices.

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TABLE 1

۔ ﺳﻌ

Feature comparisons between the MedicineLodge, Inc. Soft Tissue Anchoring Screw and a selected predicate device system (differences are indicated in bold print).

| | MLI Soft Tissue Screw
and Washer System | Mitek Screws and
Washers | Linvatec Concept Soft
Tissue Anchoring Set | Arthrotek Ligament
Screw and Washer
System |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications | MedicineLodge, Inc. soft tissue
screws and washers are indicated
for use in soft tissue graft
fixations to the femur or tibia, or
both, during cruciate ligament,
tendon or other soft tissue graft
(e.g. semitendinosus) repair
procedures. | Mitek screws and washers are
used to attach ligaments,
tendons and other soft tissue to
bone. | Concept soft tissue screws and
washers are used to attach
ligaments, tendons and other
soft tissue to bone. | Arthrotek Ligament Screw and
Washer system is designed to
produce an efficient surgical
procedure for iliotibial tenodesis
in anterior cruciate
reconstruction. |
| Materials | Ti6Al4V ELI (per ASTM F-316) | Ti6Al4V ELI (per ASTM F-316) | Ti6Al4V ELI (per ASTM F-316) | Ti6Al4V ELI (per ASTM F-316) |
| Cortical Screws | Length: 30 mm to 60 mm, in 2
mm increments
Outer Diameter: 4.5 mm | Length: 26 mm to 76 mm, in 2
mm increments
Outer Diameter: 4.5 mm | Length: 30 mm to 45 mm, in 5
mm increments; 50 mm to 70
mm with smooth proximal shank,
in 10 mm increments.
Outer Diameter: 3.5 mm | Length: 30 mm to 80 mm, in 2
mm increments
Outer Diameter: 4.5 mm |
| Cancellous Screws | Length: 20 mm to 55 mm, in 5
mm increments
Outer Diameter: 6.5 mm | Length: 20 mm to 50 mm, in 5
mm increments
Outer Diameter: 6.5 mm | Not Listed | Length: 25 mm to 55 mm, in 5
mm increments
Outer Diameter: 6.5 mm |
| ISO Conformance of
Screw Design | Yes | Yes | Yes | Yes |
| Screw Head Profile | Low profile | Low Profile | Low Profile | Low Profile |
| Surface Finish | Satin Texture | Satin Texture | Satin Texture | Satin Texture |
| Tapped/Self-tapping | Self-tapping | Self-tapping | Self-tapping | Tapped hole |
| Method of Insertion | 3.5mm Hex Driver | 2.5mm Hex Driver | 3.5mm Hex Driver | 2.5mm Hex Driver |
| Washers | Round: 14mm, 17mm, 20mm
Triangular (Delta): 17.5mm,
20.5mm
Oval (Football): 19mm, 22mm | Round: 14mm, 17mm, 20mm | Round (with post): 14mm,
17mm, 20mm
Round (Flat Washers): 14mm,
17mm | Round: 14mm, 18mm |
| Suture Holes in Washer | No | No | Yes | Yes |
| Imbrications on Distal
Surface of Washer | Yes | Yes | No | No |
| Sterilization Status | Sterile & Non-sterile | Sterile & Non-sterile | Sterile & Non-sterile | Sterile & Non-sterile |
| Manufacturer | MedicineLodge, Inc. | Mitek Surgical Products, Inc. | Linvatec, Inc. | Arthrotek, Inc. |
| Currently Marketed?
(Presumed 510(k) Approved) | N/A | Yes | Yes | Yes |